U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 1 1

Silver Spring, MD 20993

www.fda.gov

December 4, 2019

MolecuLight Inc.

℅ Joel Ironstone

President

Ironstone Product Development

Suite 222, 276 Carlaw Avenue

Toronto, M4M 3L1 Canada

Re: K191371

Trade/Device Name: MolecuLight i:X

Regulation Number: 21 CFR 878.4550

Regulation Name: Autofluorescence detection

device for general surgery and

dermatological use

Regulatory Class: Class II

Product Code: QJF, FXN

Dated: October 28, 2019

Received: October 29, 2019

Dear Joel Ironstone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced

above and have determined the device is substantially equivalent (for the indications for use stated in the

enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the

enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance

with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a

premarket approval application (PMA). You may, therefore, market the device, subject to the general

controls provisions of the Act. Although this letter refers to your product as a device, please be aware that

some cleared products may instead be combination products. The 510(k) Premarket Notification Database

located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

product submissions. The general controls provisions of the Act include requirements for annual registration,

listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We

remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be

subject to additional controls. Existing major regulations affecting your device can be found in the Code of

K191371 - Joel Ironstone Page

2

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements

concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA

has made a determination that your device complies with other requirements of the Act or any Federal

statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-

mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including

information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-

devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Purva Pandya

Acting Assistant Director

DHT4A: Division of General Surgery Devices

OHT4: Office of Surgical

and Infection Control Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

MolecuLight i:X

Indications for Use (Describe)

The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

(i) View and digitally record images of a wound,(ii) Measure and digitally record the size of a wound, and(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.

The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.

The MolecuLight i:X does not diagnose or treat skin wounds.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

K191371

K191371510(k) SUMMARY

MolecuLight i:X

Submitter’s Name, Address, Telephone Number, Contact Person and Date Prepared

MolecuLight Inc. Suite 700, 425 University Avenue Toronto, ON, Canada M5G 1T6 Phone: 647-362-4684 Contact Person: Tyler Chackowicz

Date Prepared: December 3, 2019

Name of Device

MolecuLight i:X

Device Classification and Product Code

Autofluorescence detection device, 21 CFR 878.4550, Class II, QJF Tape, Camera, Surgical, 21 CFR 878.4160, Class I, FXN

Predicate Devices

Fluobeam 800 Clinic Imaging Device (DEN170092, Predicate Device) WoundVision Scout (Class I, Predicate Device) MolecuLight i:X (DEN180008, Reference Device)

Indications for Use

The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

(i) View and digitally record images of a wound,(ii) Measure and digitally record the size of a wound, and(iii) View and digitally record images of fluorescence emitted from a wound when exposed to anexcitation light.

The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.

The MolecuLight i:X does not diagnose or treat skin wounds.

Device Description

The MolecuLight i:X Imaging Device is a handheld medical imaging device comprised of a high-resolution color LCD display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLight i:X uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.

Clinical Testing

Clinical testing was performed to evaluate the potential increase in the identification of wounds containing >104 CFU per gram of bacteria when the MolecuLight i:X is added to a clinician’s evaluation of a subject’s clinical signs and symptoms (CSS). In the study, the clinician’s interpretation of the MolecuLight i:X fluorescence image and CSS were compared to quantitative microbiological analysis. The baseline demographics of the study population is provided in the Table 1 below. Table 1 Baseline demographics of study population

Characteristic Measure All patients (n = 350)

Microbiology Positive (n=287)

Microbiology Negative (n=63)

Age (years) Mean (SD) Median (Minimum, Maximum)

60.19 (12.44) 59.76 (27.83, 96.03)

59.95 (12.11) 59.72 (27.83, 94.76)

61.27 (13.87) 60.27 (28.47, 96.03)

Sex (Female)

Count (%)

125 (35.71) 87 (30.31) 38 (60.32)

Systemic Antibiotic Use (Yes) 90 (25.71) 56 (19.51) 34 (53.97) Fitzpatrick Score Light (I or II) Medium (III or IV) Dark (V or VI)

224 (64) 83 (23.71) 43 (12.29)

179 (62.37) 74 (25.78) 34 (11.85)

45 (71.43) 9 (14.29) 9 (14.29)

The clinical testing demonstrated that the fluorescence image, when used in combination with clinical signs and symptoms (CSS), increased the likelihood that clinicians could identify wounds containing bacterial loads >104 CFU per gram as compared to examination of CSS alone. The use of the MolecuLight i:X in combination with clinical signs and symptoms resulted in a <10% increase as compared to CSS alone in the rate in wounds that were incorrectly identified as having bacterial load >104 CFU/g, whose resulting bacterial load determined by conventional microbiological analysis was <104 CFU/g.

Measure Total (%) n= 350

Sensitivity Specificity CSS+iX 60.98 84.13 CSS 15.33 93.65

No device attributable adverse events were recorded in the study. These study results demonstrated that the MolecuLight i:X increased the likelihood that clinicians can identify wounds containing wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone . The fluorescence output of the device is not ground truth regarding wound bacterial load >104 CFU/g and must be used in combination with CSS and other confirmatory methods such as bacterial culture, to make a determination of bacterial load.

Non-Clinical Testing

Nonclinical testing included the following on the subject device:

1) Standards Compliance Testing

2) Software Verification and Validation

3) System Verification and Validation

4) Cleaning and Disinfection Validation

5) Accuracy and Inter/Intra Reader Variability Testing of Wound Measurement Function

6) Bioburden Testing for the DarkDrape Accessory

7) Biocompatibility according to ISO 10993-1 including Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity for the DarkDrape and Wound Stickers.

8) Packaging and Transport validation

Compliance with Special Controls of 21 CFR 878.4550

The device complies with the all applicable special controls as per 21 CFR 878.4550 as follows:

1. A clinical study has been conducted that evaluates the device’s performance under anticipated use conditions.

2. Patient Contact Materials have been demonstrated to be biocompatible. 3. Performance testing demonstrated the electromagnetic compatibility and electrical,

mechanical and thermal safety of the device. 4. Software verification and validation has been completed. 5. LED light safety testing has been demonstrated according to IEC 60601-2-57:2011. 6. Labeling is provided that includes instructions for use as well as the performance of the device

when used as intended.

Note: There are no components labeled as sterile included with this product.

Standards Compliance

MolecuLight i:X has been tested to comply with the following FDA recognized standards:

Safety Testing per IEC 60601-1:2005+A1:2012& US National Differences per ANSI/AAMI ES 60601-1:2005/A1:2012

EMC Testing per IEC 60601-1-2:2014 4th Edition

LED Testing per IEC 60601-2-57:2011 and IEC 62471:2006 Biocompatibility according to ISO 10993-1

Software Verification and Validation Testing

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” The software for this device was considered as a “moderate” level of concern.

Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device

The intended use for both the subject device, MolecuLight i:X, and predicate device, Fluobeam 800 Clinic Imaging Device (DEN170092), are the same. Both the subject and predicate devices illuminate target tissues or structures and detect a resulting autofluorescence image using a charge-coupled device (CCD) camera. Additionally, the subject device’s wound measurement feature is similar in indication and technical characteristics to the second predicate device, WoundVision Scout. Table 2 below compares the characteristics of the subject device (MolecuLight i:X), the predicate device (Fluobeam 800 Clinic Imaging Device, DEN170092), and the reference device (MolecuLight i:X, DEN180008). Table 3 below compares the wound measurement characteristics of the subject device (MolecuLight i:X) and the predicate device (WoundVision Scout).

The subject device and the predicate devices have different technological characteristics. The submitted information, including both Non-Clinical and Clinical testing establish that the MolecuLight i:X device is at least as safe and effective as the predicate devices. Both devices operate on the principle of tissue autofluorescence, which is the property of fluorescent molecules (fluorophores) absorbing a wavelength of light and then emitting a longer wavelength of light. However, while the predicate device uses a laser for illumination, the subject device uses non-coherent light-emitting diodes (LEDs) as an excitation light source. These differences do not raise different questions of safety or effectiveness.

Table 2: Comparison of Technological Characteristics for Fluorescence Imaging

SUBJECT DEVICE ‘Modified’ MolecuLight i:X

PREDICATE DEVICE Fluobeam 800 Clinic Imaging Device (DEN170092)

REFERENCE DEVICE Granted MolecuLight i:X (DEN180008)

Device Name MolecuLight i:X Fluobeam 800 Clinic Imaging Device

MolecuLight i:X

Manufacturer MolecuLight Inc. Fluoptics MolecuLight Inc. 510(k) Number

- DEN170092 DEN180008

Regulatory Class

Class II Class II Class I

Regulation Number

QJF QDG QCR

Product Classification

21 CFR 878.4550 21 CFR 878.4550 21 CFR 878.4165

Classification Name

Autofluorescence detection device for general surgery and dermatological use

Autofluorescence detection device for general surgery and dermatological use

Wound Autofluorescence Imaging Device

Intended Use Intended for general surgery and dermatological use as an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.

Intended for general surgery and dermatological use as an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.

A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

Indications for Use

The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

(i) View and digitallyrecord images of a wound,(ii) Measure and digitallyrecord the size of a wound, and(iii) View and digitallyrecord images of fluorescence emitted from a wound when exposed to an excitation light.

The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.

The MolecuLight i:X does not diagnose or treat skin wounds.

The Fluoptics Fluobeam® Imaging system is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.

The Fluoptics Fluobeam® Imaging system can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue.

Use of the Fluobeam® device is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

(i) view and digitallyrecord images of awound, and

(ii) view and digitallyrecord images offluorescenceemitted from awound when exposed to an excitation light.

The MolecuLight i:X is for prescription use only.

Target Organ Wounds Tissue during surgical procedures

Wounds

Patient Population

Adult patients Adult patients Adult patients

Operating Modes

Standard and fluorescence imaging, video and image capture

Fluorescence imaging Standard and fluorescent imaging, video and image capture

Excitation Light

405 nm light emitted from light emitting diodes (LED)s

750 nm emitted from a laser diode

405 nm light emitted from light emitting diodes (LED)s

Laser Power Density

N/A 5 ± 1 mW/cm2 N/A

Infrared LED N/A Unknown N/A White LED N/A Broadband LEDs with normal

illumination λ<800 N/A

Table 3: Comparison of Technological Characteristics for Wound Measurement

Emission Wavelength

500-545 nm and 600-665 nm >800 nm 500-545 nm and 600-665 nm

Contrast agent

Not required – autofluorescent target

Autofluorescent target or Indocyanine green (ICG)

Not required – autofluorescent target

Working Distance

8-12 cm 20-30 cm 8-12 cm

Resolution (focal plane)

5 megapixels 300 μm to 50 μm depending on magnification

5 megapixels

Magnification N/A X10 zoom N/A Maximum Frame Rate

30 images/sec 25 images/sec 30 images/sec

Camera Bit Depth

8 bits 8 bits 8 bits

Image Size (Pixels)

1136 x 640 pixels 696 x 576 pixels 1136 x 640 pixels

Image Format JPEG PNG JPEG Video Format MOV MP4 MOV Software Operating System (OS) Compatibility

Apple iOS 9.3.5 Windows 7 or Windows 10 Apple iOS 9.3.5

Measurement Functionality

Wound length, width, and area measurements

None None

Power Supply

Battery and Wall Wall Battery and Wall

Display Handheld device; no remote display

Handheld device with remote display

Handheld device; no remote display

Patient Contacting Materials

Non-patient contacting device (held 8-12 cm from skin)

Non-patient contacting device Non-patient contacting device (held 8-12 cm from skin)

Sterility Used non-sterile Used with off-the-shelf sterile sleeve when placed in the sterile field during surgical procedures

Used non-sterile

Electrical Safety

Compliance to IEC 60601-1 Compliance to IEC 60601-1 Compliance to IEC 60601-1

Mechanical Safety

Compliance to IEC 60601-1 Compliance to IEC 60601-1 Compliance to IEC 60601-1

Chemical Safety

No chemical delivered or used as part of the system

No chemical delivered or used as part of the system

No chemical delivered or used as part of the system

Standards with which the Device Complies

IEC 60601-1-2 IEC 60601-1 IEC 60601-2-57 IEC 62471

As per K132475: IEC 60601-1-2 IEC 60601-1 IEC 60825-1

IEC 60601-1-2 IEC 60601-1 IEC 60601-2-57 IEC 62471

SUBJECT DEVICE ‘Modified’ MolecuLight i:X

PREDICATE DEVICE – Wound Measurement WoundVision Scout

Device Name MolecuLight i:X WoundVision Scout Manufacturer MolecuLight Inc. Wound Vision LLC 510(k) Number

- -

Regulatory Class

Class II Class I

Regulation Number

QDG FXN

Product Classification

21 CFR 878.4550 21 CFR 878.4160

Classification Name

Autofluorescence detection device for general surgery and dermatological use

TAPE, CAMERA, SURGICAL

Intended Use / Indications for Use

The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

(i) View and digitally record images of a wound, (ii) Measure and digitally record the size of a wound, and (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.

The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.

The MolecuLight i:X does not diagnose or treat skin wounds.

The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data. Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device. The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional. The Scout does not provide a diagnosis or therapy.

Target Organ Wounds Body parts, including wounds Patient Population

Adult patients Non-pregnant female or male patients 18 years of age or older

Patient Contacting

Non-patient contacting Non-patient contacting

Operating Modes

Standard and fluorescence imaging and video Standard and thermal imaging

Imaging Aids Non-sterile WoundStickers; DarkDrape Unknown Measurement Functionality

Measures wound length, width, and area using standard imaging

Measures the diameter, surface area, and perimeter of a part of the body or the distance between two body surfaces using a standard image and measures the thermal intensity variation data of a part of the body or two body surfaces using a thermal image

Measurement Results Part 1 (Wound Models)

Intra-rater Length: 1.59 CV% Width: 1.92 CV% Area: 2.6 CV%

Intra-rater Perimeter: 1.94 CV% Trace Area: 2.54 CV% LxW Area: 3.87 CV%

Inter-rater Length: 1.23 CV% Width: 1.28 CV% Area: 2.07 CV%

Inter-rater Perimeter: 1.97 CV% Trace Area: 2.80 CV% LxW Area: 4.20 CV%

Accuracy* Length: 3.8% Width: 3.4% Area: 4.3%

Accuracy* Perimeter: 2% Trace Area: 4%

Measurement Results Part 2 (Clinical Images)

Intra-rater Length: 2.77 CV% Width: 3.11 CV% Area: 5.02 CV%

Intra-rater Perimeter: 2.35 CV% Trace Area: 3.73 CV% LxW Area: 6.26 CV%

Inter-rater Length: 3.31 CV% Width: 5.42 CV% Area: 10.76 CV%

Inter-rater Perimeter: 3.71 CV% Trace Area: 9.29 CV% LxW Area: 9.82 CV %

Record Functionality

Electronically stores captured images, videos and measurements

Electronically stores captured images and measurements

In summary, MolecuLight i:X is substantially equivalent to the legally marketed predicate devices, Fluobeam 800 Clinic Imaging Device (DEN170092) and WoundVision Scout (for wound measurement). The intended use of the i:X device is the same as the Fluobeam, and the differences in technological characteristics do not raise different questions of safety or efficacy. In addition, the technical characteristics of the Modified MolecuLight i:X are identical to the reference device. Clinical testing and bench testing to FDA-recognized standards have demonstrated the safety and effectiveness of MolecuLight i:X with regards to differences in technological characteristics. Thus, the MolecuLight i:X is substantially equivalent to the Fluobeam and WoundVision Scout (for wound measurement).

Conclusion

MolecuLight i:X is substantially equivalent to Fluobeam and WoundVision Scout (for wound measurement).